National Cancer Institute (NCI)
National Institute of Allergy and Infectious Diseases (NIAID)

Purpose

The National Institutes of Health (NIH) of the United States
(U.S.) Department of Health and Human Services (HHS) supports international
collaborative biomedical research to advance science and expand biomedical
knowledge. Scientific cooperation between the U.S. and the People’s
Republic of China was initiated over 30 years ago and has grown rapidly in
recent years. Recognizing that enhanced cooperative biomedical research would
be of mutual benefit to the U.S. and China, the NIH Director and the President
of the National Natural Science Foundation of China (NSFC) signed a Memorandum
of Understanding (MOU) in October 2010.

NIH and NSFC further signed an Implementing Arrangement (IA)
in December 2010 to develop a new U.S.-China Program for Biomedical Research
Cooperation. A Joint Working Group (JWG), made up of a specified number of
members from both NIH and NSFC, will develop strategic plans for collaboration
and facilitate the expedited review and clearance of proposed bilateral
projects. Both the NIH and NSFC have allocated funds to support joint
activities pursued under this program.

This Notice announces an opportunity for eligible NIH
grantees to request administrative supplement support (additional funds to a
grant or cooperative agreement for unexpected administrative expenses within the
approved project scope) for their eligible active grants to enhance ongoing
research efforts through collaborations with Chinese scientists under the new
U.S.-China Program for Biomedical Research Cooperation. Based on the merit of
the requests received and the availability of funds, the NIH may award up to
$3,000,000 (total costs) in FY2011 for this effort, and the NSFC has pledged to
provide complementary funding to support the Chinese co-investigators involved
in the research collaborations.

U.S. and Chinese collaborating investigators (referred to as
co-investigators in this announcement) should work together to submit
corresponding applications in response to this announcement to NIH and NSFC. By sending an application in to NIH, the applicant in
turn agrees to provide directly a complete copy of the application to their
Chinese counterpart. The NIH will not consider for funding any application that
has not met this sharing requirement. Potential U.S. applicants concerned
about confidentiality or proprietary information should take this requirement
into account before deciding what information to submit in their application to
NIH. Applications from U.S. co-investigators will be submitted in response to this funding announcement and
reviewed administratively at NIH. NSFC will publish a corresponding funding
announcement (in Chinese) for Chinese co-investigators to apply for funding
under the joint U.S.-China Program in Biomedical Research Cooperation (see http://www.nsfc.gov.cn/Portal0/InfoModule_396/More.htm).
Applications from Chinese co-investigators will be reviewed in parallel by NSFC
using selection factors that are harmonized with NIH selection factors. Chinese
applicants will also be required to submit as part of their applications a copy
of the NIH application provided by their U.S. collaborator. Therefore, it is
expected that the Chinese collaborator will contact the U.S. PD/PI and request
copies of their application in response to this announcement for submission.
This application will also be reviewed confidentially during the NSFC review
process. Funding decisions will be made by NIH and NSFC in consultation with
the JWG and with consideration of the research priorities of both countries.

Research Objectives

Under this program, the NIH will support meritorious administrative
supplements to existing NCI and NIAID grants as well as any NIH grants in the
area of HIV/AIDS and its co-morbidities. These grants must have at least one
year of active funding remaining at the time of the administrative supplement
award on September 30, 2011. Funding under this program can be used to support new,
previously unforeseen research opportunities enhancing existing grants through
collaboration between U.S. and Chinese scientists. The
proposed research must be within the peer-reviewed scope of the
NIH-supported parent grant. NSFC will provide complementary funds as
new research grants to scientists who are current or former NSFC
grantees to support the Chinese co-investigators for these
collaborative projects.

The intent of this initiative is to foster, stimulate,
and/or expand collaborative basic, translational, and applied research between
eligible NIH grantees and eligible Chinese researchers in the areas of cancer,
allergy, immunology, and infectious diseases including HIV/AIDS and its co-morbidities.

Basic, translational, behavioral, clinical, preventive, or
epidemiological research may be proposed under this program. Clinical
trials of drugs, biologics or diagnostics will NOT be supported through this
program. Examples of research areas that are responsive to this announcement
include, but are not limited to:

In
cancer:

Studies on the pathobiology of cancers in China or the U.S.

Studies of rare tumors where there is a benefit to U.S.-China
cooperation to identify sufficient numbers of cases for study

Studies of traditional Chinese medicine (TCM) to 1) identify
novel therapeutics in the pharmacopeia of traditional medical systems as
defined by the World Health Organization (http://www.who.int/medicines/areas/traditional/definitions/en/index.html);
2) use of complementary approaches to improve the therapeutic ratio of standard
and investigational anti-cancer therapies; or 3) conduct research on lifestyle
modifications (e.g. diet, exercise, mind-body approaches) and their effect on
cancer outcomes (e.g. response to conventional cancer therapy, survival)

Administrative supplements will be limited to 25 percent of
the Institute Advisory Council-approved direct costs for the current budget
year of the project or $100,000 direct costs, whichever is less. Awards
will be for one year and the existing grant must have at least one (1) year of active
funding remaining at the time that the supplement is awarded on September 30,
2011.

NSFC will provide complementary funds (approximately 300,000
Renminbi (Chinese currency) per project) for the Chinese co-investigators to
engage in these projects. Five percent of the NSFC total award amounts can be
used for indirect costs by Chinese institutions.

Eligibility

To be eligible, the parent NIH grant must be active, and the
research proposed in the supplement must be accomplished within the remaining
time of the award. The proposed supplement must be within the general scope of
the peer-reviewed activities and aims approved within the parent grant. Current
NCI or NIAID grantees funded in cancer, allergy, immunology, infectious diseases,
and HIV/AIDS and its co-morbidities with at least one (1) year of active funding
remaining as of September 30, 2011, are eligible to apply. Grantees at other
NIH institutes funded in the area of HIV/AIDS and its co-morbidities are also
eligible. Funding under this program will support collaborative
research projects only and cannot be used to support research infrastructure.
Funding under this program can be used to support new,
previously unforeseen research opportunities enhancing existing grants through
collaboration between U.S. and Chinese scientists. The
proposed research must be within the peer-reviewed scope of the
NIH-supported parent grant. . Applicants must propose to work with Chinese
scientists who are current or former NSFC grantees. NSFC has
additional eligibility requirements for Chinese co-investigators to apply for
NSFC funding under this program which are described in detail in the corresponding
NSFC funding announcement published on its website at www.nsfc.gov.cn (only in Chinese). Applications
are only responsive to this announcement if the Chinese co-investigator submits
a corresponding application to NSFC. The NIH grant mechanisms eligible
under this announcement are: active R01; P01; U01; U19; U54; P30 (as pilot
projects to the Developmental Core with no additional funding to infrastructure);
and P50 awards.

IMPORTANT:
The research proposed by the NIH grantee in the administrative supplement request
must be within the original scope of the NIH-supported parent grant. The funding mechanism being
used to support this program, i.e., administrative supplements, can be used to
cover increased cost
associated with achieving certain new research objectives as long as they are
within the original scope of the parent grant.

Eligible
Chinese co-investigators may propose a new project in the corresponding application to NSFC, as NSFC will grant new, 1-year
awards under the jointly funded program.

Applicants
are encouraged to ensure that each administrative supplement request includes
two budgets: one requesting NIH funding (for expenses on the U.S. side) and one
budget requesting NSFC funding (for expenses on the Chinese side in Chinese currency). Both the U.S. and Chinese applications
should include the same title for the collaborative project written in English.

Letters of Interest (Only for U.S. Investigators)

Letters
of Interest (LOIs) are optional and non-binding. Before
submitting an LOI, U.S. applicants are strongly encouraged to discuss the
feasibility of their research application with the program officer or project
scientist of the parent grant. LOIs should be no longer than two pages and
should include the following information:

Name of NIH-funded Principal Investigator, grantee institution,
title of grant, grant number of parent grant, names and address of Chinese
collaborator and affiliated Chinese institution; and

LOIs may be submitted at any time, but must be received at
the NIH no later than 5:00PM Eastern Time on March 14, 2011.

Submitting an Administrative Supplement Request

To be considered for an administrative supplement, the
request must be signed by the Authorized Organizational Representative/Signing
Official (AOR/SO) and the PD/PI of the application, and must describe the need
for additional funding and categorical costs.

Please
note that Chinese co-investigators will be required to submit the contents of
the entire NIH application to NSFC (in addition to the NSFC application) for
review. This application copy will also be confidentially reviewed during the
Chinese review. It is expected that the Chinese collaborator
will contact the U.S. PD/PI and request copies of their application for
submission.

Applicants are strongly
encouraged to submit requests electronically as an attachment in pdf format via email; however,
the signature of the Authorized
Organizational Representative (AOR)must be clearly visible. Administrative supplement requests may
be submitted at any time, but must
be received by no later than 5:00PM Eastern Time on April 14,
2011.

As an alternative, requests
can be submitted via CD to be mailed to the point of contact listed
below (with the signature of the Authorized Organizational Representative [AOR]clearly visible in the
application) and must be postmarked no later than April 7, 2011.

Requests should be submitted on the PHS398
Application Guide forms (font size and other formatting rules apply as
designated in the instructions), as indicated below. Include only the following
elements:

Cover
Letter, which cites this Notice and contains the following information:

Project Director/Principal Investigator (PD/PI) name;

Parent NIH grant number and title;

Title of the U.S-China collaboration project;

Amount of the requested supplement;

Name and title of the institutional official;

Phone numbers, email addresses, and delivery addresses for both
the PD/PI and institutional official; and

This Notice should be cited in Box 2, and the “yes” box should be
checked.

The Project Director/Principal Investigator (PD/PI) must be the
same as the PD/PI on the parent award. For Multiple PD/PI parent awards,
the Contact PD/PI must be the PD/PI listed on the supplement request, and the
supplement cannot change the Multiple PD/PI team.

The remaining items on the face page should be filled out in
accordance with the PHS 398 application instructions.

PHS
398 Form Page 2

Note: The project “summary” is that of the administrative
supplement, not the parent grant. The name of the U.S.-China collaboration
project should be included at the beginning of the project summary section. An
identical title (in English) should be included in the corresponding
application to NSFC.

A
brief application describing the project that is being proposed in collaboration with the Chinese
co-investigator, containing:

A research
plan that does not exceed five pages (excluding bibliography
and references) including:

Brief description of the scope of the overall project on which the
supplemental request is based;

Relationship of the supplement request to the parent grant and the anticipated
contribution of the requested supplement;

Specific aims; and

Research strategy, including research design, methods, and data analysis.

Other required components of the application (submitted in
addition to the research plan) are:

Letter
of confirmation co-written and co-signed by the U.S. and
Chinese co-investigators, and including the Authorized Organizational Representative (AOR)
signature. The first section of the letter of confirmation should
describe specific responsibilities of the U.S. PD/PI and Chinese partner. This
letter should detail available resources, including which collaborative partner
is contributing which resources, and a plan for how resources will be shared
(e.g., individual contributions of specific reagents, patient samples,
compounds, and access to populations for epidemiologic studies). The second
part of the letter of confirmation should address the benefit of U.S.-China
collaboration for this project, explaining why there is a need for
international collaboration, what is the synergy between the collaborating
groups, and how the project will achieve intellectual balance between the
respective partners (three-page limit).

Biographical
sketches for all new key personnel who are additions on the
supplemental project (two-page limit for each biographical sketch).

Roles of
key staff (three-page limit)

A discussion of future plans for expanding, extending, or otherwise
continuing the research jointly prepared with the Chinese partner(s) (one-page
limit).

Budget for the supplement with a justification that details the items requested,
including personnel, travel, and Facilities and Administrative (F&A) costs. The
applicant is encouraged that each application includes two budgets: one
requesting NIH funding (for expenses on the U.S. side) and one budget
requesting NSFC funding (for expenses on the Chinese side in Chinese currency [Renminbi]).

Human
subjects/vertebrate animal documentation (if applicable).

Include a current Human Subjects/Institutional Review Board (IRB)
or Vertebrate Animals/Institutional Animal Care and Use Committee (IACUC)
approval letter, if available. Otherwise, this will be required at the time of
funding. All appropriate IRB and IACUC approvals must be in place prior to a
supplement award being made.

Any differences in the involvement or use of human subjects or
specimens, or use of vertebrate animals, between the administrative supplement
activity and the parent grant should be noted.

When appropriate, details should be provided on the protection of
human subjects and inclusion of women, children, and
minorities. Additional guidance on Human Subjects Research and Vertebrate
Animals is provided under Part II of the PHS 398 instructions.

The grantee institution must show evidence of compliance with
U.S. and Chinese regulations for the conduct of research involving human
subjects. Additional information can be found at the HHS Office for Human
Research Protections website at http://www.hhs.gov/ohrp.

PHS 398 Checklist Form.

Selection

Administrative supplement requests will be evaluated
administratively by NIH Staff. Selection factors will include the following:

Relevance of the proposed activities to the parent grant;

Adequate progress of the parent grant appropriate to the current stage
of the project;

Appropriate and well-described plan to accomplish the goals
within the timeframe proposed; and

Expertise of the research team proposed to conduct and achieve
the goals the supplemental study.

Reviewers also will examine the appropriateness of the
budgets in consideration of the study proposed and the research environment for
the scientific projects.

Additional
selection factors include:

Significance. Does the project address an important
problem or a critical barrier to progress in the field? If the aims of the
project are achieved, how will scientific knowledge, technical capability,
and/or clinical practice be improved? How will successful completion of the
aims change the concepts, methods, technologies, treatments, services, or
preventative interventions that drive this field?

Investigator(s). Are the PD/PIs, collaborators, and
other researchers well suited to the project? If submitters are Early Stage
Investigators or New Investigators, do they have appropriate experience and training?
If established, have they demonstrated an ongoing record of accomplishments
that have advanced their field(s)? Do the investigators have complementary and
integrated expertise; are their leadership approach, governance and
organizational structure appropriate for the project?

Innovation. Does the proposed research challenge
and seek to shift current understanding or clinical practice paradigms by
utilizing novel theoretical concepts, approaches, or methodologies,
instrumentation, or interventions? Are the concepts, approaches or
methodologies, instrumentation, or interventions novel to one field of research
or novel in a broad sense? Is a refinement, improvement, or new application of
theoretical concepts, approaches or methodologies, instrumentation, or
interventions proposed?

Approach. Are the overall strategies, methodology,
and analyses well-reasoned and appropriate to accomplish the specific aims of
the project? Are potential problems, alternative strategies, and benchmarks for
success presented? If the project is in the early stages of development, will
the strategy establish feasibility and will particularly risky aspects be
managed?
If the project involves research in human populations, are the plans for: 1)
protection of human subjects from research risks; and 2) inclusion of
minorities and members of both sexes/genders, as well as the inclusion of
children, justified in terms of the scientific goals and research strategy
proposed?

Environment.Will the scientific environment in
which the work will be done contribute to the probability of success? Are the
institutional support, equipment and other physical resources available to the
investigators adequate for the project proposed? Will the project benefit from
unique features of the scientific environment, subject populations, or
collaborative arrangements?

Inquiries

Inquiries and discussion of plans for responding to this
Notice are strongly encouraged.